[Clearside Biomedical Q1 2025 Earnings Release](index=1&type=section&id=Clearside%20Biomedical%20Q1%202025%20Earnings%20Release) [Corporate Update and Program Highlights](index=1&type=section&id=Corporate%20Update%20and%20Program%20Highlights) Clearside Biomedical advanced CLS-AX to Phase 3, saw partner milestones, and featured its SCS Microinjector® platform in over 15 presentations - Reached alignment with the FDA on the **Phase 3 program design** for CLS-AX in wet AMD, targeting a **flexible three-to-six-month maintenance dosing schedule**, which is believed to offer a commercially compelling product profile[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - Development partner BioCryst Pharmaceuticals received authorization to initiate its **first clinical trial in Australia** for avoralstat for Diabetic Macular Edema (DME), with **initial data expected in 2025**[2](index=2&type=chunk)[6](index=6&type=chunk) - Asia-Pacific partner Arctic Vision's New Drug Application (NDA) for ARCATUS® was **accepted for review in China** and **approved in both Australia and Singapore** for the treatment of uveitic macular edema (UME)[2](index=2&type=chunk)[6](index=6&type=chunk) - The company's suprachoroidal drug delivery platform was featured in **over 15 presentations** at major ophthalmic medical meetings, including ARVO 2025, indicating growing interest in the technology[1](index=1&type=chunk)[6](index=6&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Clearside reported increased Q1 2025 revenue to **$2.3 million**, reduced net loss to **$8.2 million**, and maintained **$13.6 million** in cash, funding operations into Q4 2025 Q1 2025 Statement of Operations Highlights (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | | Research and development | $4,463 | $5,615 | | General and administrative | $2,824 | $2,824 | | Loss from operations | ($5,205) | ($8,209) | | Net loss | ($8,223) | ($11,763) | | Net loss per share | ($0.11) | ($0.17) | - The increase in revenue was primarily attributable to **$1.5 million** in milestones from partner Arctic Vision and **$0.8 million** in other revenue for training, services, and sales of SCS Microinjector kits[6](index=6&type=chunk) - The decrease in R&D expenses was primarily due to lower clinical trial costs following the completion of the ODYSSEY Phase 2b trial[6](index=6&type=chunk) Balance Sheet Summary (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,628 | $20,020 | | Total assets | $19,668 | $25,126 | | Total liabilities | $65,578 | $63,981 | - As of March 31, 2025, cash and cash equivalents totaled **$13.6 million**. The company believes it has sufficient resources to fund planned operations into the **fourth quarter of 2025**[9](index=9&type=chunk)

Core Insights - Clearside Biomedical has successfully completed an End-of-Phase 2 meeting with the FDA, leading to alignment on the Phase 3 program design for CLS-AX in wet AMD [1][5] - The company aims for a flexible three-to-six-month dosing label for CLS-AX, which is expected to be commercially attractive if approved [2][5] - Significant progress has been made by Clearside's partners in advancing their programs, including approvals and ongoing clinical trials [2][5] Recent Highlights - BioCryst Pharmaceuticals has received authorization to initiate its first clinical trial in Australia for avoralstat, targeting diabetic macular edema [5] - Arctic Vision's NDA for ARCATUS has been accepted for review in China, with approvals already granted in Australia and Singapore [5] - Over 15 presentations on suprachoroidal drug delivery were made at major ophthalmic medical meetings this year, showcasing advancements in retinal disease treatments [1][5] Financial Results - License and other revenue for Q1 2025 was $2.3 million, a significant increase from $0.2 million in Q1 2024, primarily due to license fees from partners [8][11] - R&D expenses decreased to $4.5 million in Q1 2025 from $5.6 million in Q1 2024, attributed to lower clinical trial costs [8][11] - The net loss for Q1 2025 was $8.2 million, or $0.11 per share, compared to a net loss of $11.8 million, or $0.17 per share, in Q1 2024 [8][11] Company Overview - Clearside Biomedical focuses on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, aiming to improve patient outcomes [6] - The company's lead program, CLS-AX, is in development for the treatment of wet AMD, with plans for a Phase 3 program underway [6] - Clearside has developed its first product, XIPERE, which is commercially available in the U.S. through a partner [6][9]

Core Insights - Clearside Biomedical, Inc. is advancing the treatment of multiple macular diseases through its suprachoroidal drug delivery platform, highlighted by positive clinical data for its lead program, CLS-AX [1][2] Presentation Highlights - Six presentations at the ARVO 2025 Meeting showcased the efficacy and safety of CLS-AX, particularly its ability to maintain stable best corrected visual acuity (BCVA) while reducing injection frequency in patients with neovascular age-related macular degeneration (nAMD) [1][5] - The Phase 2b ODYSSEY trial demonstrated that CLS-AX offers durability and therapeutic potential, achieving its primary outcome [5] - The suprachoroidal delivery method is positioned as a transformative approach for treating retinal diseases, with Clearside recognized as a leader in this field [2][5] Technological Innovations - Clearside has developed a machine learning algorithm for imaging the suprachoroidal space (SCS) post-drug delivery, enhancing patient data evaluation [5] - The SCS Microinjector, designed for targeted drug delivery, has completed over 15,000 injections, establishing a clinically validated training program [5][9] Product Development - CLS-AX is a proprietary suspension of axitinib, a tyrosine kinase inhibitor, which has shown a positive safety profile in clinical trials and aims to provide prolonged and targeted delivery for retinal diseases [8][10] - The company is also planning a Phase 3 trial for CLS-AX and evaluating other small molecules for potential long-acting treatments [10]

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [3] - The company utilizes a patented SCS Microinjector for targeted and compartmentalized delivery of therapies, aiming to improve patient outcomes in sight-threatening eye diseases [3] - Clearside's lead program, CLS-AX (axitinib injectable suspension), is in development for treating neovascular age-related macular degeneration (wet AMD), with planning for a Phase 3 program underway [3] Product Development - Clearside has developed its first product, XIPERE (triamcinolone acetonide injectable suspension), which is approved for suprachoroidal use and available in the U.S. through a commercial partner [3] - The company is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - Clearside strategically partners its SCS injection platform with other companies utilizing ophthalmic therapeutic innovations [3] Financial Information - The company will report its first quarter 2025 financial results on May 14, 2025, after the close of financial markets [1] - There will be no conference call hosted for this quarter [1]

Clearside Biomedical (CLSD) Conference Summary Company Overview - Clearside Biomedical focuses on delivering drugs to the back of the eye through the suprachoroidal space, positioning itself as a leader in this innovative approach [3][4] - The company has successfully navigated the FDA regulatory pathway and has conducted over 15,000 injections using its SCS Microinjector [3] Core Products and Pipeline - The internal pipeline includes CLS AX, a phase three ready asset for wet age-related macular degeneration (AMD), and preclinical candidates for geographic atrophy [4] - Collaborations with partners include: - Bausch + Lomb commercializing XIPERE for uveitic macular edema - AbbVie REGENX entering phase three for diabetic retinopathy with gene therapy - Aura in phase three for choroidal melanoma - BioCrysta preparing for clinical trials for diabetic macular edema (DME) [4] Suprachoroidal Space Advantages - The suprachoroidal injection method is less invasive compared to traditional intravitreal injections, reducing the risk of complications such as endophthalmitis [6][7] - The method allows for more contained drug delivery, potentially leading to less inflammation and better targeting of ocular conditions [10] CLS AX Candidate Insights - CLS AX targets the ocular anti-VEGF market, which is valued at approximately $101 billion [12] - The drug aims to extend the duration of treatment effects from the current average of 1-4 months to 3-6 months, providing a significant improvement in patient management [12][14] - The use of a TKI (tyrosine kinase inhibitor) instead of biologics differentiates CLS AX from competitors, allowing for more flexible dosing schedules [13][14] Phase Two Data and Phase Three Design - In phase two trials, approximately two-thirds of patients requiring frequent injections were able to maintain vision for six months without additional therapy [16] - The company plans to adjust the phase three trial design based on learnings from phase two, including earlier redosing and aligning with real-world clinical practices [26][42] - The focus will be on a general patient population rather than just the most active patients, which may provide a more accurate representation of treatment efficacy [40] Financial Considerations - As of the end of the previous year, Clearside Biomedical reported approximately $20 million in cash, which is expected to support the initiation of phase three trials [46] - The projected cost for each phase three study is estimated to be between $55 million and $60 million [46] Market Dynamics - The competitive landscape includes other companies using intravitreal methods, which may have limitations in terms of frequency and invasiveness [21][24] - The company acknowledges the importance of flexible dosing options, as seen with competitors like Vabismo, which has gained traction due to its every four-week option [24] Conclusion - Clearside Biomedical is positioned to leverage its innovative suprachoroidal delivery method and promising pipeline to capture significant market share in the ocular treatment space, with a focus on patient-centric approaches and real-world applicability in its clinical trials [49]

Wall Street expects a year-over-year increase in earnings on higher revenues when Clearside Biomedical, Inc. (CLSD) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they mi ...

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at delivering therapies to the macula, retina, or choroid [3] - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, targeting neovascular age-related macular degeneration (wet AMD) [3] Product Development - The company is planning a Phase 3 program for its lead product, CLS-AX (axitinib injectable suspension) [3] - Clearside is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - The first product developed by Clearside, XIPERE (triamcinolone acetonide injectable suspension), has been approved for suprachoroidal use and is available in the U.S. through a commercial partner [3] Upcoming Events - Management will participate in a fireside chat at the Citizens Life Sciences Conference on May 7, 2025, at 1:00 p.m. ET [1] - A live and archived webcast of the event will be accessible on the Clearside website under the Investors section, with the archive available for three months [2]

A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months. ALPHARETTA, Ga., April 01, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS), announced today that George Lasezkay, PharmD, JD, President and Chief Executive Office ...

Core Viewpoint - Clearside Biomedical, Inc. is conducting a conference call to discuss its Q4 2024 financial results and corporate updates, indicating a focus on future expectations and company performance [1]. Group 1: Company Overview - The conference call is hosted by Jenny Kobin from Investor Relations, highlighting the company's commitment to transparency and communication with stakeholders [2][3]. - The call includes key participants such as the CEO George Lasezkay, Chief Medical Officer Victor Chong, and CFO Charlie Deignan, indicating a comprehensive leadership presence [1]. Group 2: Forward-Looking Statements - The company will be making forward-looking statements regarding its future expectations, plans, and prospects, which are subject to various important factors that could lead to actual results differing materially from these statements [4]. - It is emphasized that these forward-looking statements reflect the company's views as of the date of the call and may not be updated in the future, indicating a cautious approach to future projections [5].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately $20 million, which is expected to fund operations into the fourth quarter of 2025 [36] - The company is actively pursuing options to fund the CLS-AX Phase 3 program, including potential partnerships with third parties [36] Business Line Data and Key Metrics Changes - The company reported positive results from the ODYSSEY Phase 2b wet AMD clinical trial, leading to a successful end of Phase 2 meeting with the FDA regarding planned Phase 3 activities for CLS-AX [7][29] - The SCS Microinjector has been used for over 15,000 suprachoroidal injections, indicating strong interest from retinal specialists and pharmaceutical companies [6] Market Data and Key Metrics Changes - The wet AMD market represents over $12 billion in annual sales, with the company positioning CLS-AX as a maintenance treatment to capture a significant share [31] - The company’s partner, Arctic Vision, achieved regulatory milestones in the Asia-Pacific region, with product approvals in Australia and Singapore, and a new drug application under review in China [9] Company Strategy and Development Direction - The company aims to maximize the commercial potential of CLS-AX through a pivotal Phase 3 program designed to reduce regulatory risk and enhance market competitiveness [29][30] - The strategy includes targeting treatment-naive patients to potentially expand the commercial value of CLS-AX [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase 3 trial design and its potential to demonstrate the efficacy of CLS-AX, emphasizing the importance of reducing variability in patient selection [29][84] - The company is optimistic about the broad applicability of suprachoroidal delivery in treating serious retinal diseases, with ongoing evaluations of small molecules for geographic atrophy [32] Other Important Information - The company is the only TKI in development with multi-dosing data from its Phase 2b trial and the ability to re-dose before six months, which is seen as a significant differentiator [29] - The company is preparing for participation in upcoming healthcare conferences to further engage with stakeholders [36] Q&A Session Summary Question: How might the amendments to the planned Phase 3 improve results from Phase 2? - Management believes that excluding patients with higher disease variability will lead to better results in the general population [45][46] Question: How long will it take to enroll the treatment-naive population? - Enrollment is expected to take around 12 months, based on recent trials [48] Question: What is the estimated cost of the Phase 3 program? - While specific costs were not disclosed, similar Phase 3 trials have been around $55 million to $60 million [55] Question: How will the redosing criteria work? - Redosing will rely on OCT biomarkers, with a focus on intraretinal fluid, and will be distinct from rescue criteria [95][100] Question: Will the inclusion criteria impact enrollment speed? - Management anticipates minimal impact on enrollment speed, estimating that less than 10% of patients would be rejected based on the new criteria [84]